Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name implant, endosseous, root-form
510(k) Number K122052
Device Name MINIFIX BALL MINIFIX ONE
Applicant
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
118 W. PRIVE CR.
DELRAY BEACH,  FL  33445
Applicant Contact JUAN TEZAK
Correspondent
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
118 W. PRIVE CR.
DELRAY BEACH,  FL  33445
Correspondent Contact JUAN TEZAK
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/12/2012
Decision Date 11/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-